Deployment actuation system for intrafallopian contraception

ABSTRACT

Contraceptive methods, systems, and devices generally improve the ease, speed, and reliability with which a contraceptive device can be deployed transcervically into an ostium of a fallopian tube. The contraceptive device may remain in a small profile configuration while a sheath is withdrawn proximally, and is thereafter expanded to a large profile configuration engaging the surrounding tissues, by manipulating one or more actuators of a proximal handle with a single hand. This leaves the other hand free to manipulate a hysteroscope, minimizing the number of health care professional required to deploy the contraceptive device.

CROSS-REFERENCES TO RELATED APPLICATIONS

[0001] This application is a continuation application which claims thebenefit of priority of U.S. patent application Ser. No. 09/644,287(Attorney Docket No. 016355-003910US), filed on Aug. 22, 2000, whichclaims the benefit of priority from U.S. Patent Application Serial No.60/150,238 filed on Aug. 23, 1999, and is related to application U.S.patent application Ser. No. 09/644,277, (Attorney Docket No.16355-003810), entitled “Insertion/Deployment Catheter System forIntrafallopian Contraception”, which was filed concurrently therewith,the full disclosures of all of these incorporated herein by reference.

STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSOREDRESEARCH OR DEVELOPMENT

[0002] NOT APPLICABLE

REFERENCE TO A “SEQUENCE LISTING,” A TABLE, OR A COMPUTER PROGRAMLISTING APPENDIX SUBMITTED ON A COMPACT DISK.

[0003] NOT APPLICABLE

BACKGROUND OF THE INVENTION

[0004] The present invention generally relates to medical devices,systems, and methods. In a particular embodiment, the invention providestemporary or permanent intrafallopian contraceptive devices, deliverysystems, and non-surgical methods for their deployment.

[0005] While the theoretical effectiveness of existing non-surgicalcontraceptive techniques, including barrier methods and hormonaltherapies, is well established, the actual effectiveness of most knownmethods is disappointing. One reason for these disappointing results isthat many of the presently available methods for inhibiting pregnancywithout surgery depend upon significant user involvement. Non-compliancetypically results in quite high rates of failure, and overcoming usernon-compliance to improve overall efficacy has proven quite difficult.

[0006] One form of long term contraception which is less susceptible touser non-compliance is the intrauterine device (IUD). IUDs have beenfound to have higher rates of reliability, and are effective for alonger period of time, then most other commercially availablecontraceptives. Unfortunately, IUDs are also associated with seriousinfectious complications. For this reason, the use of IUDs within theUnited States has decreased dramatically. Additionally, fUDs are subjectto unplanned expulsion, and are removed due to excessive pain orbleeding in a significant percentage of cases, further reducingacceptance of the IUD as a method of inhibiting pregnancy.

[0007] Commercially available options for permanent sterilizationinclude fallopian tube ligation and vasectomy. These methods aresurgical and are not available to many people in the world. It is commonknowledge that fertilization occurs in the fallopian tubes where thesperm and ovum meet. Tubal ligation avoids this by surgical and completeocclusion of the fallopian tubes.

[0008] In work done in connection with the present invention, it haspreviously been proposed to transcervically introduce a resilient coilinto a fallopian tube so as to inhibit conception. PCT PatentApplication No. 99/15116, assigned to the present assignee (the fulldisclosure of which is incorporated herein by reference) describesdevices which are transcervically inserted into a tubal ostium andmechanically anchored within the fallopian tube. The described devicesmay promote a tissue ingrowth network to provide long term conceptionand/or permanent sterilization without the need for surgical procedures,and should avoid the risks of increased bleeding, pain, and infectionassociated with intrauterine devices.

[0009] While the recently proposed intrafallopian contraceptive devicesrepresent a significant advancement in the art, still furtherimprovements would be desirable. In general, it would be desirable toprovide improved non-surgical devices, systems, and methods forinhibiting pregnancy. It would be beneficial if these improvedtechniques increased the ease, speed, and reliability with which thesecontraceptive devices could be deployed. It would be further beneficialif these improved access and deployment techniques could safely andeffectively be performed without numerous assistants, and if they didnot require expensive medical equipment so that they could beimplemented by health care professionals in an outpatient clinic. Someor all of these advantages are provided by the device describedhereinbelow.

SUMMARY OF THE INVENTION

[0010] The present invention generally provides improved medicaldevices, systems, and methods. The techniques of the present inventionare particularly useful for improving the ease, speed, and reliabilitywith which contraceptive devices can be deployed transcervically into anostium of a fallopian tube. The invention generally providesintrafallopian contraceptive systems having a handle adapted formanipulation and actuation by a single hand of a healthcare provider.Typically, the handle includes at least one actuator which can bemanipulated by the same hand used to grip the handle. In manyembodiments, the healthcare provider can advance the contraceptivedevice into an ostium of a fallopian tube by manipulating the handle,can withdraw a sheath from around the contraceptive device, can expandthe contraceptive device from a small profile configuration to a largeprofile configuration, and/or can detach the expanded contraceptivedevice from the remaining components of the contraceptive system,ideally all with one hand. Advantageously, this leaves the other handfree to grasp and manipulate a hysteroscope, allowing the healthcareprovider to orient the system toward the tubal ostium and effect itsdeployment while optically viewing and verifying the deployment, ratherthan relying on coordinating the efforts of two separate individuals toaccess the target site and deploy the contraceptive device. Deploymentmay, alternatively, be directed under a variety of imaging modalities,including ultrasound, fluoroscopy, or possibly even with tactileguidance. Mechanically coupling the various elongate deploymentcomponents to a common proximal housing can also avoid confusion overwhich component is to be moved, and which is to be maintained at a fixedposition. Hence, the invention facilitates deployment of intrafallopiancontraceptive devices in a wide variety of healthcare settings.

[0011] In a first aspect, the invention provides a contraceptivedelivery system comprising a contraceptive device expandable from asmall profile configuration to a large profile configuration. Thecontraceptive device in the small configuration is insertable into anostium of a fallopian tube. A first elongate body has a proximal end anda distal end with a receptacle disposed adjacent the distal end. Thereceptacle releasably receives the contraceptive device. A proximalhandle is disposed at the proximal end of the first elongate body. Thehandle has a size and shape suitable for gripping with a single hand. Atleast one actuator is mounted on the handle. The actuator is moveable bythe hand while the hand grips the handle so as to expand thecontraceptive device to the large profile configuration and affix thecontraceptive device within the ostium of the fallopian tube.

[0012] Preferably, the contraceptive delivery system will furtherinclude a sheath having a lumen that slidably receives the receptacle sothat movement of the at least one actuator withdraws the sheathproximally from the contraceptive device. This arrangement allows thehealthcare provider to maintain the position of the contraceptive deviceby holding the handle at a fixed position with the same hand that isused to move the actuator. This leaves the other hand free to supportthe hysteroscope, which will often be used to optically direct thedeployment procedure.

[0013] The system will often further include means for expanding theuncovered contraceptive device after the sheath has been withdrawn. Theexpansion means will often be coupled to the contraceptive device andwill be operable by the actuator. Separating at least a portion of theexpansion and sheath withdrawal mechanisms can help avoid resilientexpansion forces from acting against the sheath, which forces mightimpede movement of sheath and make it difficult to hold thecontraceptive device accurately in position during deployment. While avariety of expansion means may be provided (such as inflation balloonsand fluid lumens for plastically deforming a stent-like structure, orthe like), the preferred expansion means comprises a second elongatebody which moves relative to the first elongate body to effect expansionof the contraceptive device after the sheath is withdrawn. In theexemplary embodiment, the first and second elongate bodies restrain aresilient outer helical coil of the contraceptive device by maintaininga torque until the at least one actuator moves a second elongate body.

[0014] In some embodiments, a first movement of a dual-function actuatorrelative to the handle moves the sheath relative to the first elongatebody without moving the second elongate body relative to the firstelongate body. A second movement of the dual-function actuator after thefirst movement moves the second elongate body relative to the firstelongate body. Optionally, a latch may releasably restrain movement ofthe second elongate body relative to the first elongate body. As thefirst elongate body will often releasably hold the contraceptive device,this can keep the device at the target location during at least a partof the deployment procedure. The first elongate body may threadinglyengage the contraceptive device, and may be decoupled from thecontraceptive device by rotating the handle or a decoupling actuator.

[0015] In another aspect, the invention provides a contraceptivedelivery system comprising a contraceptive device which is expandablefrom a small profile configuration to a large profile configuration. Thecontraceptive device in the small configuration is insertable into anostium of a fallopian tube. A first elongate body has a proximal end anda distal end. A receptacle is disposed adjacent the distal end of thefirst elongate body. The receptacle releasably receives thecontraceptive device. A sheath has a lumen which slidably receives atleast a portion of the contraceptive device. A second elongate bodyextends proximally from the contraceptive device to a proximal end. Ahandle is disposed at the proximal end of the first elongate body. Thehandle has at least one actuator, and a first movement of the at leastone actuator withdraws the sheath proximally from the contraceptivedevice. A second movement of the least one actuator moves the secondelongate body relative to the first elongate body so as to expand thecontraceptive device to the large profile configuration.

[0016] In yet another aspect, the invention provides a medical devicecomprising an elongate guiding structure having a proximal end and adistal end. The guiding structure is laterally flexible and increases inflexibility toward the distal end so that the guiding structure issuitable for distally tracking a body lumen. A proximal handle isaffixed adjacent the proximal end of the guiding structure. The handlehas a slot that laterally receives the guiding structure adjacent thedistal end. A detent is capable of restraining the guiding structurewithin the slot to facilitate introducing the distal portion into alumen.

[0017] In a method aspect, the invention comprises inserting acontraceptive device transcervically into an ostium of a fallopian tubeby gripping a handle with a hand of a healthcare worker and moving thehand. The handle is coupled to the contraceptive device by an elongatebody. The inserted contraceptive device is expanded by moving anactuator on the handle while the hand grips the handle. The expandedcontraceptive device is detached from the elongate body so that thecontraceptive device inhibits conception.

[0018] Generally, a hysteroscope is manipulated by another hand of thehealthcare worker to orient the contraceptive device toward the ostiumwhile the healthcare worker views an image of the ostium with thehysteroscope. This allows the healthcare worker to simultaneouslymanipulate these two components of the contraceptive delivery system,avoiding complex coordination between two individuals.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019]FIG. 1 illustrates the uterine and tubal anatomy for deployment ofthe contraceptive devices of the present invention.

[0020]FIG. 1A schematically illustrates method steps for an exemplarycontraceptive device deployment method.

[0021]FIG. 1B is a partial cut-away side view of a contraceptive systemaccording to the principles of the present invention.

[0022]FIG. 2 is a side view of a removable core wire of thecontraceptive system of FIG. 1B.

[0023]FIG. 3 is a contraceptive device of the contraceptive system ofFIG. 1B, in which an outer helical coil is in a large profileconfiguration.

[0024]FIG. 3A is an end view of the contraceptive device of FIG. 3.

[0025]FIG. 3B illustrates a contraceptive device having a tubular bandfor smoothly disengaging a release pin of a release catheter.

[0026]FIG. 4 is a side cross-section of a distal end of a deliverycatheter of the contraceptive system of FIG. 1B.

[0027]FIG. 4A is an axial cross-sectional view of the delivery catheterof FIG. 4.

[0028]FIG. 5 is a side cross-sectional view of an outer sheath of thedelivery system of FIG. 1B.

[0029] FIGS. 5A-5F illustrate sheaths having positioning surfaces foraxially positioning the contraceptive device relative to the tubalostium.

[0030]FIG. 6 is a partial cut-away view showing engagement between theouter helical coil of the contraceptive device and the release catheterso as to maintain the wind-down torque on the outer helical coil.

[0031]FIG. 7 is a perspective view of the proximal handle of thecontraceptive system of FIG. 1B.

[0032]FIGS. 8A and 8B illustrate a syringe-like handle for use with thecontraceptive system of FIG. 1B.

[0033]FIGS. 9A and 9B illustrate a further alternative pistol griphandle for use with the contraceptive system of FIG. 1B.

[0034]FIG. 10 is a perspective view of a preferred proximal handle ofthe contraceptive system of FIG. 1B having a thumb wheel, latch, androtation knob for exposing, expanding, and releasing the contraceptivedevice at the target location.

[0035]FIG. 11 is a perspective view of an alternative in-line sliderhandle for use with the contraceptive system of FIG. 1B.

[0036]FIGS. 11A through 11K schematically illustrate a method fordeploying a contraceptive device using the system of FIG. 1B.

[0037]FIGS. 12A and 12B are side and axial end views schematicallyillustrating the use of an indentation in the handle to facilitateintroducing the guidewire-like distal end of the contraceptive deliverysystem into a lumen, such as the working lumen of a hysteroscope.

[0038]FIG. 13 illustrates an alternative deployment method using analternative imaging system.

[0039]FIGS. 14A and 14B illustrate a deployment system having a sleevedisposed around the outer sheath, and use of the sleeve to inhibitinadvertent movement of the contraceptive device when the outer sheathis retracted.

[0040]FIG. 15 schematically illustrates a side view of alternativedistal components for a contraceptive system.

[0041]FIG. 16 illustrates an alternative coupling structure at aproximal end of an outer helical coil used in the alternativecontraceptive system of FIG. 10.

[0042]FIG. 17 schematically illustrates a contraceptive system having aseparate positioning catheter slidably disposed over the sheath, thepositioning catheter having a positioning surface to assist in axiallypositioning of the contraceptive device.

[0043]FIG. 18 illustrates a method for using the positioning surface ofa sheath or positioning catheter to assist in axially positioning of thecontraceptive device.

[0044]FIG. 19 schematically illustrates a side view of a contraceptivesystem, showing axially coupling of the positioning catheter to thecontraceptive device.

[0045]FIG. 20 schematically illustrates a lateral cross-section of analternative outer sheath of the delivery system of FIG. 1B.

[0046]FIG. 21 schematically illustrates an alternative proximal handleof the contraceptive system.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

[0047] The present invention provides a contraceptive device, system,and method which can be used to inhibit pregnancy, typically for thelong-term inhibition of pregnancy, and often providing permanentcontraception or sterilization. By introducing at least a portion ofthese contraceptive devices into an ostium of a fallopian tube, therisks of unplanned expulsion, pelvic pain, and infectious complicationsmay be significantly reduced. Although the present invention may beincluded within a group of contraceptive techniques generally referredto as fallopian tube occlusion methods, the invention need not beadvanced fully into the fallopian tube, and in some embodiments, neednot fully block the tubal lumen to effectively disrupt fertilization. Asdescribed in co-pending International Patent Application No. 99/15116,assigned to the present assignee (the full disclosure of which isincorporated herein by reference), contraception may optionally beprovided by fully occluding the tubal lumen, and/or by sufficientlydisrupting the fertilization process without total occlusion. In someembodiments, including a bioactive material such as copper may enhancethe devices effectiveness.

[0048] As used herein, a structure is inserted “within a tubal ostium”whenever the structure is advanced from the uterus into (and optionallybeyond) the tubal ostium into the uterotubal junction and/or thefallopian tubes.

[0049] Referring now to FIG. 1, access to uterus U will generally begained through cervix C. From within uterus U, fallopian tubes F areaccessed via tubal ostiums O.

[0050] Fallopian tubes F generally include three segments between ostiumO and the fimbria FIM. Beginning adjacent uterus U, the intramuralsegment INT of fallopian tubes F are surrounded by the muscular uterinetissues. Beginning at uterotubal junction UTJ, fallopian tubes F extendbeyond the uterine tissues and within the peritoneal cavity along anisthmic segment ISC, and then along an ampullary segment AMP.

[0051] In general, the ideal placement for the intrafallopiancontraceptive devices of the present invention is spanning theintramural INT to isthmic ISC portion of the fallopian tube. Where aradially expandable attachment mechanism such as an outer coil isincluded on the intrafallopian contraceptive device, that expandable oranchoring structure will preferably span the uterotubal junction UTJ. Itshould be noted that the uterotubal junction UTJ may be defined as theplane where the fallopian tube meets the peritoneal cavity. It shouldalso be noted that the narrowest portion of the fallopian tube need notnecessarily be disposed in the isthmic segment ISC, particularly oncethe contraceptive fallopian device (often having a radially expandableanchoring structure) is deployed therein. In fact, work in connectionwith the present invention has shown that the effectively narrowestportion of the tube may be at or adjacent the uterotubal junction UTJ.

[0052] Referring now to FIG. 1A, an overview of an exemplary method 2for deploying and using the contraceptive devices of the presentinvention is helpful to understand the selection of structures used inthose devices. It should be understood that not all steps need beperformed in every deployment. Nonetheless, reviewing the exemplarydeployment method 2 will help to understand the structures describedhereinbelow.

[0053] Identification of the anatomy and target location 3 allows theoperator to determine the preferred placement of the contraceptivedevice within the ostium, and also to determine if any specialcircumstances are present for a particular device placement procedure.Anatomy and target location identification can be facilitated using avariety of known visualization modes, including hysteroscopy, sonography(ultrasound), fluoroscopy, and the like. Hence, an exemplarycontraceptive device may be adapted to delivery using more than oneimaging modality.

[0054] The exemplary contraceptive device will also preferably be ableto accommodate a wide variety of anatomies. Two factors contribute tothe importance of this variability: First, a wide variation may beobserved between tubal anatomies of differing patients. Secondly, it canbe quite difficult to determine and identify the specific tubal anatomyof a particular patient. As a result, the preferred contraceptive devicemay incorporate safeguards allowing sufficiently accurate placement(with tolerance for normal operator error), as well as for the variancein the length and diameter of the various segments of the fallopiantube.

[0055] Exemplary deployment method 2 in FIG. 1A will also includepositioning of the device at the target location 4. Once again, a widevariety of techniques might be used to assist a healthcare professionalin positioning the device in the correct location, includingvisualization techniques, providing high-contrast markers (such asradiopaque markers, echogenic markers, or the like), providing tactileindication of the placement position by including physical stops or“bumpers” (which may be adapted to engage reference tissues in such atactile way as to send a signal to the healthcare professional), or thelike. Device positioning can be significantly facilitated by providingan appropriate device and/or deployment system design having the properflexibility, navigation characteristics, friction reduction surfaces,small delivery profile, coatings, and the like. Once again, devicepositioning 4 will preferably compensate for anatomical variations,operator error, and difficulties in visualization so as to help promoteaccurate placement.

[0056] In the exemplary deployment method 2, the device is deployedand/or expanded at the target location in the step indicated byreference numeral 5. Optionally, the device and/or deployment system mayallow visualization and/or confirmation of device expansion whileexpansion takes place.

[0057] Generally, the contraceptive device will be detached from itsdeployment system at the target location in step 6. Once again, it ishelpful to provide visualization and/or confirmation of detachment,which may be provided visually, via ultrasound, fluoroscopy, or thelike. It should be understood that a wide variety of detachmentmechanisms might be used to decouple the device from the deploymentsystem.

[0058] In the exemplary method, it should be possible to confirm theposition of the device at the target location 7. Confirmation may beprovided, once again, by visualizing at least a portion of the deviceafter detachment, often using the same visualization modality usedduring placement. In addition to optical visualization techniques, thismay be provided by including radiopaque markers for fluoroscopicplacement confirmation, sonographic markers for ultrasound placementconfirmation, or the like. Optionally, specific marker locations may beprovided along the contraceptive device 2, for example, to indicate thespecific locations of proximal and/or distal ends of the device.

[0059] Exemplary method 2 further includes a step 9 for anchoring andstability of the device at the target location. Aspects of this stepinclude accommodating visualization of the device so as to monitor it'sstability. Anchoring of the device at the target location may includeanchoring on an acute basis (such as using an expanded helical coil thatcan adjust and adapt to variations in the tubal lumen, an expandedstent-like structure, expanded braid, or the like) and long-term (suchas may be provided by including a fiber mesh or lattice which incites atissue reaction such as ingrowth, thereby providing fibrous tissueswhich affix the device in place within the fallopian tube). Similarly,stability will preferably be provided for both a short-term and along-term, typically by designing a device with the proper resiliencyand shape to accommodate physiological movement without shifting. Thedevice will preferably be wear-profile balanced to provide sufficientanchoring without inducing pain or losing its stability due to erosionfor the life of the patient.

[0060] The final step indicated on the exemplary method 2 of FIG. 1A isefficacy. This may be provided by incorporating a lumen/space fillingdesign that sufficiently alters the function and architecture of thefallopian tube so as to inhibit conception. This may include the use ofpolyester fibers to incite the desired tissue reaction.

[0061] In general, the devices of the present invention may be adaptedto incite a reaction tissue response in the fallopian tube through thepresence polyester fibers, or the like. Ideally, this reaction can beclassified as a highly localized, benign tissue reaction. The reactionresults in the incorporation of the contraceptive device into the tuballumen tissues, so that the device is firmly embedded into thesurrounding tissue structure. This reaction can typically becharacterized by the proliferation of smooth muscle cells and associatedfibrosis. Additionally, the tubal lumen will generally exhibit anabsence of the normal tubal architecture which is generally necessaryfor conception. The tubal lumen may also be obstructed, occluded, and/orfunctionally occluded by the presence of the device and associatedfibrosis sufficiently to inhibit conception. The reaction is a benignone, and there appears to be no change in anatomy or structure of theouter tubal wall beyond approximately 5 to 10 mm radially outwardly fromthe outer coil of the device. Similarly, normal tubal architecture willoften be visible about 5 mm axially beyond the device (typically distalof the device, as the device often extends into the uterus), againindicating a very localized reaction.

[0062] Referring now to FIG. 1B, an exemplary contraceptive system 10generally includes a contraceptive device 12, a sheath 14 partiallysurrounding the contraceptive device, a release catheter 16, and a coreshaft 18. Contraceptive device 12 generally has a proximal portion 20adjacent a proximal end 22 (disposed within sheath 14), and a distalportion 24 adjacent a distal end 26 (which are exposed beyond the distalend of sheath 14). Distal portion 24 generally functions as a distalguidewire while system 10 is advanced within the tubal ostium. Proximalportion 20 includes a radially expandable structure which can beexpanded after sheath 14 is withdrawn so as to affix the contraceptivedevice in the deployed position.

[0063] Sheath 14 is generally a tubular structure having a distal end 28and extending proximally to a proximal handle 30. Sheath 14 willgenerally have a length in a range from about 25 to about 50 cm, andwill typically have an outer diameter in a range from about 0.020 toabout 0.060 inches, the exemplary sheath having a length of about 39.5cm and an outer diameter of about 0.04 inches. The inner diameter ofsheath 14 may be in a range from about 0.02 inches to about 0.05 inches,with the exemplary sheath having an inner diameter of about 0.33 inches.

[0064] Release catheter 16 generally comprises a tube having a distalend 34 which releasably engages contraceptive device 12, and a proximalend coupled to housing 30 via actuator 33.

[0065] In the exemplary embodiment, core shaft 18 comprises a resilienttapering structure extending from within distal portion 24 ofcontraceptive device 12 proximally to handle 30. Core shaft 18threadably engages contraceptive device 12 proximally of distal end 28of sheath 14. In the exemplary embodiment, core shaft 18 and releasecatheter 16 transmit a wind-down torque onto an expandable structure ofthe contraceptive device so as to maintain the expandable structure inthe small profile configuration. Hence, releasing core shaft 18 relativeto release catheter 16 allows the expandable structure to be activatedindependently of movement of the surrounding sheath.

[0066] Handle 30 includes a housing 31 having a size and shape suitablefor gripping with a single hand. A thumb wheel actuator 33 performs twoactuation functions: first, rotation of the thumb wheel relative tohousing 31 draws sheath 14 proximally by engagement between pinion 35(attached to the thumb wheel) and rack 37 (attached to sheath 14).During this initial movement, release catheter 16 is restrained relativeto housing 31 by latch 39. Once the proximal end of rack 37 engages acooperating surface attached to release catheter 16, latch 39 can beactuated to allow release catheter 16 to move relative to the housing asthe thumb wheel 33 is again turned in the direction shown. In someembodiments, spring 51 may be compressed by rotation of the thumb wheelprior to actuation of latch 39, so that actuation of the latch slidesthe release catheter so as to disengage the release catheter fromcontraceptive device 12. In this embodiment, a proximal end of coreshaft 18 is affixed to the housing so that the core shaft is rotated byrotating the entire housing.

[0067] Components of housing 31 and actuators 33, 39, will generallycomprise polymers, metals, or the like. The actuator mechanism mayinclude molded and/or machined parts, and may be permanently attached tosheath 14, release catheter 16, core shaft 18, and the like so that theremaining components of the delivery system 10 are disposed of oncecontraceptive device 12 has been deployed. Alternatively, it may bepossible to provide sterilizable, reusable, and/or responsible deliverysystem components if desired.

[0068] In the exemplary embodiment, housing 31 has an overall length ina range from about 2 to about 8 inches, ideally having a length of about7.5 inches. The exemplary embodiment of rack 37 has a length of about5.5 cm and a total travel stroke of about 4.0 cm. Release catheter 16has a stroke of about 1 cm, and movement of the release catheterrelative to core shaft 18 is inhibited prior to actuation of latch 39.Unthreading of core shaft 18 from device 12 will typically be completein about 10 rotations or less, ideally being unthreaded with from aboutone quarter to about 2 full rotations of the handle (or other rotationalmechanism).

[0069] While exemplary contraceptive device 12 makes use of a radiallyexpandable helical coil to help restrain the structure during tissueingrowth, a wide variety of mechanical and other restraint mechanismsmight be included. For example, alternative mechanical anchors might beattached to the device, such as resilient coils biased to form bends,loops, and/or other secondary shapes having enhanced cross-sections,slotted tubes, Malecot-type structures, radially expandable braids,stent-like devices, and the like. The mechanical structures may beresilient, plastically deformable, or the like, and suitable structuresare described in more detail in, for example, PCT Publication No. WO99/15116.

[0070] Still further device-restraint techniques might be employed,including thermal, chemical, adhesive, and the like. These techniquescan be used to avoid expulsion by increasing friction between the deviceand the surrounding tissues, by imposing limited tissue damage topromote scar tissue formation, and/or by promoting tissue ingrowth intothe device. Thermal techniques may include, for example, transmission ofelectrical or laser energy along contraceptive system 10. Resistiveheating of contraceptive device 10 might be effected by applying anelectrical potential across the device with conductors extending alongsheath 14 and release catheter 16, laser energy along an optical waveguide attached to core wire 18, or the like. Monopolar tissuedesiccation might be effected via a large return electrode patch byenergizing core wire 18 with radiofrequency energy, or an adhesiveand/or caustic agent (such as a cyanoacrylate or silver nitrate) mightbe introduced via any of the lumens of the delivery system, via adedicated lumen or structure, or the like. Biodegradable plugs and thelike might also be included, and the retained structure may optionallycomprise copper or other bioactive agents to help inhibit conception.

[0071] Tissue reaction to the retained contraceptive device 12 can helpto provide long term contraception and/or sterilization. To promoteconception inhibiting tissue reaction, device 12 will often include atissue reaction material, the material often comprising fibers. Thefibers may comprise a polyester, such as Dacron® polyesters, silk,nylon, or the like. The fibers may be in the form of a weave, a knit, abraid, a felt, or the like, or may comprise stands attached to thedevice body.

[0072] The components of contraceptive system 10 can be furtherunderstood with reference to FIGS. 2 through 5, in which thesecomponents are illustrated individually. Beginning with FIG. 2, coreshaft 18 tapers to a gradually increasing diameter proximally of distalend 40 so as to provide increasing support of distal portion 24,proximal portion 20, and the catheter structures proximal ofcontraceptive device 12. This increasing support (and the associatedincrease in column strength) enhances the pushability of thecontraceptive system while accessing the target deployment site. Threads42 threadingly engage a coil of the contraceptive device, and aregenerally formed by affixing a coil with separated windings to a centralcore wire at a bond 44. A tube 43 may also be affixed at bond 44 toprevent binding and/or jumping of the cooperating threads, the tubeideally comprising stainless steel, platinum, or the like. In theexemplary device, core shaft 18 comprises a high strength metallicstructure.

[0073] The exemplary contraceptive device 12 is illustrated in moredetail in FIG. 3. Contraceptive device 12 includes a primary coil 50which extends from a distal ball tip 52 to proximal threads 54, whichmay conveniently be formed by separating the proximal windings of theprimary coil. The expandable structure, here in the form of a helicalouter coil 56, has a proximal end bent to form a wind-down attachment58, and has a distal end affixed to coil 50 at coil bond 60. Fiber 62extends between the inner and outer coils, and is also disposed withinprimary coil 50 so as to promote tissue ingrowth throughout thecross-section of contraceptive device 12. The arrangement of coilattachment 58 and position of fiber 62 can be seen in the axial view ofFIG. 3A. By making use of a contraceptive device having a distal portion24 which can act as a guidewire, no open lumen need be provided throughthe center of the contraceptive device (for example, for a separateguidewire), and multiple access/deployment steps (for example, accessingthe target location with a guidewire, advancing a catheter over theguidewire, removing the guidewire from the positioned catheter, and thenadvancing the contraceptive device) can be avoided. While the exemplarysystem uses threads to couple the core wire (or other deployment shaft)to the contraceptive device, a variety of alternative detachableconnections might be used, including cooperating keys/slots, connectors,or the like.

[0074] In the exemplary embodiment, coil 50 is formed of a high strengthresilient material, ideally comprising stainless steel wire having adiameter of about 0.005 inches, and wound to form a coil having an outerdiameter of about 0.022 inches. Ball tip 52 preferably has across-section which is larger than the cross-section of coil 50, theball tip generally having a diameter in a range from about 0.020 inchesto about 0.050 inches, the exemplary ball tip having a diameter of 0.027inches.

[0075] Helical coil 56 comprises a highly elastic high strength metalwhich is biased to expand from the low profile configuration illustratedin FIG. 1 to the larger profile configuration illustrated in FIG. 3 whenreleased within the target site. In the exemplary embodiment, outer coil56 comprises a ribbon of a superelastic shape memory alloy, and has athickness of about 0.001 inches and a width of about 0.015 inches, withthe ribbon being biased to form a helical coil having an outer diameterof about 0.080 inches and a length of about 3.5 cm when not otherwiserestrained. Outer coil 56 is preferably fixed to primary coil 50 by abond 60 of solder. Bond 60 will preferably be separated from ball tip 52by a distance in a range from about 0.3 cm to about 1.0 cm.Advantageously, bond 60 may be aligned with the distal end 28 of sheath14 so as to help present an atraumatic increase in diameter betweendistal portion 24 of contraceptive device 12 and the sheathed proximalportion 20 prior to deployment.

[0076] Fiber 62 may comprise a polyester, or the like. The fiber may beloosely woven or matted strands, with at least one end of the fibersaffixed to primary coil 50 or outer coil 56.

[0077] Generally, the expandable structure will at least help holdcontraceptive device 12 in place until tissue ingrowth occurssufficiently so as to permanently retain the contraceptive device.Hence, the expandable structure will often benefit from a relativelyhigh friction outer surface. Such an outer surface might make itdifficult to advance the contraceptive device into position if thedevice is advanced without sheath 14.

[0078] Work in connection with the present invention has shown thatresiliently expandable structures which have sufficient strength toreliably hold the contraceptive device within the ostium of thefallopian tube may impose significant frictional forces against asurrounding sheath. These frictional forces can significantly complicatethe accurate delivery of contraceptive device. Hence, outer coil 56 ispreferably maintained in a small profile configuration within sheath 14by applying a wind-down torque between core wire 18 and release catheter16. The core wire can transfer the wind-down torque to outer coil 16through cooperating threads 42, 54, with the direction of the wind-downtorque preferably being arranged so that the wind-down torquediscourages decoupling of the threads. In other words, rotation of corewire 18 relative to contraceptive device 12 in a direction opposed tothe wind-down torque is used to detach core wire 18 from contraceptivedevice 12.

[0079] A slight variation upon the wind-down attachment is illustratedin FIG. 3B. An alternative contraceptive device 12 a includes a smalltube or band 59 soldered within a small diameter proximal section of theouter coil 56. Band 59 can have a relatively large interface area withcoil 56 to facilitate bonding. Use of the band helps avoid stressconcentrations, and also presents a smooth inner lumen which may inhibitbinding of the release catheter. Band 59 may comprise stainless orplatinum, ideally having an inner diameter of about 0.023 inches and anouter diameter, with a thickness of the surrounding outer coil andsolder bond, of about 0.030 inches. A similar band 59′ may be disposedwithin threads 54 of coil 50 to provide a radiopaque marker, and toinhibit thread jump. Band 59′ may be similar in structure to band 59,but shorter in length. Still further alternative attachment mechanismsare possible. For example, a mass or knob may be formed at the proximalend of outer coil 56 from a simple ball of solder, coil material, bend,or the like. This mass may be slidably receivable within slot of thedelivery catheter.

[0080] The distal structure of release catheter 16 is shown in FIGS. 4and 4A. The wind-down torque is releasably transferred between outercoil 56 and release catheter 16 by cooperation between bend 58 and pin66 at the distal end 34 of the release catheter 16. Release catheter 16generally includes a tubular body 68 formed of rigid polymers such aspolyimide. Pin 66 is disposed within a lumen of tubular body 68, and issupported within the tubular body by a helical support coil 70 andadhesive 72. Interestingly, the tubular body dimensions may be driven bythe wind-down torque transferred proximally by release catheter 16.

[0081] The structure of sheath 14 is illustrated in more detail in FIG.5. Distal end 28 (see FIG. 5A) of sheath 14 will preferably be rounded,with the distal end ideally cooperating with coil bond 60 ofcontraceptive device 12 so as to avoid friction and facilitate distalnavigation of delivery system 16 through the uterotubal junction andinto the fallopian tube. The rounded distal end 28 may optionally berounded along both the inner and outer diameter of sheath 14, or mayprimarily be rounded along the outer diameter so as to taper inwardlydistally.

[0082] Sheath 14 will preferably have a multi-layer structure, with thelayers comprising (beginning at the outside) a hydrophilic coating 76 toreduce friction during tracking and navigation. Such hydrophiliccoatings become quite slippery when exposed to fluid. Below hydrophiliccoating 76 is a structural layer of a polymer 78 such as Tecoflex™ alongthe proximal portion of sheath 14, and a reinforcing braid 80 of ametal, ideally of stainless steel, is disposed within a layer ofpolyimide below polymer layer 78. Along the more distal portion ofsheath 14, metal braid 82 is disposed within polymer layer 78 ofTecoflex™, or the like, and the polyimide layer is absent so as toprovide enhanced flexibility. The inner lumen of sheath 14 is defined bya low friction polymer coating 84, the low friction polymer ideallycomprising a PTFE such as Teflon®. Exemplary sheaths 14 may becommercially available from a variety of vendors. Suitable structuresmay be described in more detail in published PCT patent application WO98/57589, the full disclosure of which is incorporated herein byreference.

[0083] As schematically illustrated in FIGS. 5A through F, alternativesheaths 14A, B, and C, include bumpers 57, 57′, and 57″, respectively.Bumper 57 has an outer surface extending radially from the outer surfaceof the underlying sheath. Although bumper 57 may optionally provide atactile indication that the sheath 14A is advancing distally beyond thetarget deployment position, it does not necessarily prevent the sheathfrom advancing so that the bumper can enter into the tubal ostium.Bumper 57 may also provide a visible marker that hinders pushing of thesheath so that the bumper moves past the ostium. Optionally, bumper 57may comprise a colored adhesive, or may comprise a clear adhesive with acolored band of material disposed underneath.

[0084] Alternative bumpers 57′ and 57″ may comprise polymer or metallicstructures, ideally comprising a polyethylene or a super-elastic,shape-memory alloy. These radially expandable bumper structures can becollapsed for delivery through a working lumen of a hysteroscope, andcan then expand to impede advancement of the sheath by engaging theuterine tissue adjacent to the tubal ostium.

[0085] Referring now to FIG. 6, the sliding engagement between pin 66 ofrelease catheter 16 and bend 58 of outer coil 56 is more clearlyillustrated. FIG. 6 also shows how the wind-down torque imposed on theouter coil by the core shaft 18 and release catheter 16 help maintainthe outer coil in a small profile configuration within sheath 14,allowing the sheath to be withdrawn easily. The wind-down torque can bereleased by sliding release catheter 16 so that pin 66 slides free ofbend 58. Optionally, the release catheter may first be allowed to rotaterelative to the core shaft to reduce the engagement forces between bend58 and pin 66.

[0086] Referring now to FIG. 7, thumb wheel 33 and latch 39 areconveniently located for actuation by a thumb of a surgeon, nurse, orother healthcare professional while the healthcare professional gripshandle 30 with the remaining fingers of the hand. This allows thehealthcare professional to perform several of the deployment steps witha single hand. In general, movement of overall housing 31 is used toadvance contraceptive device 12 distally into the tubal ostium, and tonavigate the contraceptive delivery system within the uterotubaljunction and fallopian tube. Once the contraceptive device ispositioned, thumb wheel 33 withdraws sheath 14 from over thecontraceptive device, while housing 31 continues to rotationally andaxially couple the proximal ends of the release catheter 16 and coreshaft 18, thereby maintaining the wind-down torque on the contraceptivedevice so as to restrain the contraceptive device in its small diameterconfiguration.

[0087] Once the proximal portion of the contraceptive device is exposed,latch 39 can be depressed and thumb wheel 33 can again be turnedproximally to disengage pin 66 of release catheter 16 from thewound-down outer coil of the contraceptive device, thereby radiallyexpanding the contraceptive device. Advantageously, prior to expansion,it may be possible to withdraw the contraceptive device proximally backinto the sheath 14 and/or slightly reposition the contraceptive devicewithin the tubal ostium if desired.

[0088] Once the contraceptive device has been both exposed and expanded,handle 30 is rotated as illustrated to threadingly disengage core shaft18 from the contraceptive device 12. Hence, handle 30 allows thehealthcare professional to position the contraceptive device, expose thecontraceptive device, actuate the contraceptive device so as to affixthe device to the surrounding tissue, and decouple the contraceptivedevice from the remaining components of the delivery system with asingle hand.

[0089] As can be understood with reference to FIGS. 8A through 11, awide variety of alternative one-handed release handles might be usedwith the contraceptive delivery system of FIG. 1B. Referring now toFIGS. 8A and B, an axial motion “T” handle 30 a uses a syringe-typeaxial pull motion to pull sheath 30 back with the fingers of a handtowards a palm of the hand (which is generally held at a fixedposition). This effects axial motion of sheath 14 to withdraw the sheathfrom over the contraceptive device, followed by axial motion of releasecatheter 16 to allow the contraceptive device to expand. Optionally, aknob 41 may be affixed to the proximal end of core shaft 18, so thatrotation of knob 41 threadingly disengages the core wire from theexpanded contraceptive device. Knob 41 may include a releasable latchcoupling the knob to the housing to prevent rotation of the core shaftand maintain the wind-down torque until release is desired.Advantageously, axial motion handle 30 a allows for multiple hand sizesand various hand positions, and presents a form which is familiar todoctors.

[0090]FIGS. 9A and B illustrate a still further alternative pistol griphandle 30 b for effecting one-handed deployment of the contraceptivedevice. In this embodiment, a trigger actuator 43 moves sheath 14 andrelease catheter 16 via a bead chain 45 and a bead chain drive wheel andgear arrangement. After actuation of the trigger actuator 43 with, forexample, and index finger of the hand, a latch button (not shown) may bedepressed and knob 41 rotated by a thumb of the hand to decouple thecontraceptive device from core shaft 18.

[0091] Referring now to FIG. 10, a preferred one-handed release handle30 c includes a thumb wheel 33 which, when turned relative to thesurrounding housing, initially causes movement of sheath 14 relative tocore shaft 18 as will be described in detail herein below. Once thecontraceptive device has been uncovered, depressing safety latch 39allows the thumb wheel to again be rotated so as to move releasecatheter 16 relative to the core shaft to allow the contraceptive deviceto expand. These movements of thumb wheel 33 can easily be performedwhile maintaining the housing of preferred handle 30 c at a fixedlocation, thereby avoiding movement to the contraceptive device. Oncedeployment has exposed and expanded the contraceptive device at thetarget location, knob 41 may be rotated, again while holding theremaining handle at a fixed location. The internal mechanism providingthese movements is illustrated in FIGS. 11D, 11E, 11F, and 11H.

[0092] Still further alternative one-handed release handles may beprovided, including an in-line slider handle 30 d having a thumb slide47 for sequential movement of the sheath 14 and then release catheter 16relative to core shaft 18, as shown in FIG. 10. A knob 41 may be allowedto rotate relative to the housing by depressing a latch 39, or theentire housing may be rotated to detach the engagement threads, asdescribed above.

[0093] An exemplary method for use of contraceptive system 10 can beunderstood with reference to FIGS. 11A through 11K. Preferably, ahealthcare worker will manipulate contraceptive delivery system 10 witha first hand H1 while supporting an imaging and/or access device such asa fluoroscopy catheter, sonography catheter, or hysteroscope S with asecond hand H2. This allows the healthcare professional to personallycontrol the orientation of distal advancement of the contraceptivesystem and its movement and deployment while viewing the procedurethrough the scope S (shown here schematically by eye E). While scope Sis illustrated here as a simple optical device, it should be understoodthat a variety of scope structures are encompassed by the system andmethod of the present invention, including rigid optical scopes, scopeshaving a coherent fiber optic bundles, scopes which includecharge-couple devices (CCD's) for displaying an image of the procedurein a monitor, and the like). Exemplary hysteroscopes for use with thepresent invention are commercially available from Richard Wolf ofChicago, Ill. under model name 5 MM OVAL SCOPE.

[0094] Referring now to FIG. 11B, system 10 is introducedtranscervically through uterus U, generally under optical direction.Using hysteroscope S the physician directs the distal end of the systemtoward ostium 0 of fallopian tube F. Uterus U may be irrigated and/ordistended using scope S and/or a separate irrigation or gas insufflationsystem. Once ostium O is located and the scope S is oriented toward theostium, system 10 is advanced distally through the working lumen of thescope and into the ostium using distal portion 24 of the contraceptivedevice as a guidewire, while the remainder of the contraceptive deviceremains covered by sheath 14.

[0095] The outer hydrophilic coating of sheath 14 minimizes frictionwhile advancing system 10, and the sheath also provides structuralcolumn strength to the system. The distal ball tip of distal portion 24aids tracking and navigation through fallopian tube F, while the primarycoil structure flexes laterally to track the tortuous bends often foundwithin the fallopian tube. In the exemplary embodiment, core wire 18extends into distal portion 24 to enhance column strength of the distalportion beyond sheath 14, but does not extend to the ball tip. Hence,the stiffness of distal portion 24 increases proximally, furtherenhancing the distal portion's ability to track the lumen.

[0096] In the exemplary embodiment, sheath 14 includes a visual marker98 which can be seen from the scope of hysteroscope S. Marker 98 willpreferably be positioned partially within ostium O and partially withinuterus U, thereby indicating that contraceptive device 12 is disposed atthe target position, as the sheath, core shaft, and contraceptive deviceare releasably locked together during advancement and positioning anopening (as the sheath, core shaft, and contraceptive device arereleasably locked together during advancement and positioning). Asdescribed above, marker 98 may comprise a bumper, a structure whichextends radially from the sheath to provide a tactile positioningindication.

[0097] Preferred positioning of contraceptive device 12 is illustratedin FIG. 11C. Preferably, device 12 extends across the uterotubaljunction UTJ, with the device ideally extending both proximally anddistally of the uterotubal junction. The intermural section INT (seeFIG. 1) typically has a length in a range from about 1 to about 2 cm,and outer coil 56 will preferably extend proximally beyond ostium O intouterus U by a distance in a range from about 0.2 to about 1.2 cm. Outercoil 56 will preferably extend distally of the intermural section INTand/or uterotubal junction UTJ by a distance of at least about 0.6 cm.As the uterotubal junction UTJ is adjacent muscular tissues which areoften higher in strength than the delicate tubal tissues of the moredistal sections of fallopian tube F, the narrowest portion of thefallopian tube (particularly after deployment of device 12) will oftenbe found adjacent the uterotubal junction. Extending the expandablestructure both distally and proximally of this narrowing can provideanchoring against proximal and distal movement of the device, therebyavoiding movement of contraceptive device 12 from the target positionwhile tissue ingrowth takes place. Advantageously, positioning accuracywith a range of about 1 cm may be provided by limiting marker 98 to a 1cm length. This provides a sufficient positional tolerance for ease ofuse while helping to ensure reliable, well-anchored deployments.

[0098] Referring now to FIGS. 11C, 11D, and 1B, positioned contraceptivedevice 12 is deployed by first withdrawing sheath 14 from over theexpandable structure. Using the embodiment of FIG. 10, thumb wheel 33 isrotated proximally by thumb TH to draw sheath 14 proximally from overthe contraceptive device. Handle 30 is held in a fixed position, whilethe thumb wheel is rotated, so that core shaft 18 maintainscontraceptive device 12 at the target location within the tubal ostium.Once rack 37 engages the corresponding proximal structure of releasecatheter 16, further movement of sheath 14 and thumb wheel 33 will beimpeded until latch 39 is depressed, as can be understood with referenceto FIG. 11B. At this time, device 12 has been positioned at the targetlocation, and sheath 14 has been withdrawn proximally allowing theproximal portion of the contraceptive device to be viewed from Scope soas to verify initial positioning.

[0099] Referring now to FIGS. 1F, 11G, and 11H latch 39 is depressed soas to allow the proximal structure of release catheter 16 to be movedaxially by rack 37. After latch 39 is depressed, thumb wheel 33 canagain be rotated so as to draw both sheath 14 and release catheter 16proximally relative to core shaft 18. As seen in FIG. 11H and describedabove with reference to FIG. 6, this rotationally decouples the outercoil of the contraceptive device from the release catheter 16, allowingthe release catheter to expand.

[0100] While the dual action thumb wheel and safety latch mechanismillustrated in FIGS. 11F and 11G is preferred, a variety of alternativeuncovering/expansion mechanisms may be employed. For example, referringagain to FIG. 1B, spring 51 hinders rotation of thumb wheel 33 untillatch 39 is depressed. Optionally, spring 51 may store sufficient energyto move release catheter 16 relative to core shaft 18 when latch 39 isactuated, or spring 51 may be entirely absent so that latch 39 allowsthe thumb wheel to expand the expansible structure by moving both sheath14 and release catheter 16 relative to the core shaft 18.

[0101] Once core shaft 14 has been withdrawn from over the expandablestructure and release catheter 16 has been disengaged from the exposedexpandable structure resiliently expands and affixes contraceptivedevice in place, handle 30 may be rotated to disengage the contraceptivedevice 12 from the remaining components of delivery system 10. Referringonce again to FIGS. 11F and 11G, sliding proximal structure 16 aattached to proximal end of release catheter 16 proximally allows aproximal structure 18 a of core shaft 18 to rotate. More specifically,splines on the proximal structure of the release catheter are movedaxially beyond cooperating splines on the proximal structure of the coreshaft. The core shaft proximal structure 18 a is rotationally coupled toknob 41, so that the cooperating splines prevent rotation of the knobprior to the deployment's stroke of the release catheter, but thereafterallow the knob to be rotated so as to facilitate decoupling of coreshaft 18 from the contraceptive device.

[0102] Referring now to FIGS. 11, 11J, and 11K, once the proximalstructures of the release catheter and core shaft 16 a and 18 a havemoved so that knob 41 is free to rotate, the operator rotates the knobusing thumb TH and/or the fingers of the hand holding release handle30C. As described above, the direction of rotation of the core shaft fordisengagement will be generally opposed to that imposed by the wind-downtorque, so that the wind-down torque helps maintain threaded engagement.Once core shaft 18 is unthreaded from contraceptive device 12, handle30, sheath 14, release catheter 16, and core shaft 18 may be withdrawnproximally into and/or through the scope S. Scope S may be remain withinuterus U and another delivery system may be inserted into the scope fordeployment of a contraceptive device in the ostium of the opposedfallopian tube. After deployment of both contraceptive device in the twofallopian tubes, and after the scope is used to visually verify bothdeployments have been successful, the scope is withdrawn transcervicallyfrom the uterus, as illustrated in FIG. 11K.

[0103] Referring now to FIGS. 12A and B, a slotted handle 30 dpreferably includes a slot 100 which laterally receives sheath 14 whenthe distal portion of delivery system 10 is bent as shown. As can beseen most clearly in the view along the distal axis of the deliverysystem shown in FIG. 12B, slot 100 fittingly receives sheath 14 adjacentthe distal end of the delivery system. Detents 102 extend from thehousing into slot 100 and restrain sheath 14 within slot 100 against theresilient straightening forces from the sheath, from release catheter16, and from core shaft 18.

[0104] The elongate components of delivery system 10 which extenddistally from handle 30 d to the distal end of distal portion 24 presentan elongate guiding structure with a lateral flexibility which increasesdistally toward the distal end. By releasably securing this self-guidingstructure within slot 100, the guiding structure can be easily insertedinto a working lumen W of hysteroscope S using handle 30 d. This avoidshaving a long flexible guidewire-like structure extending in cantilevera considerable distance from the handle, or having the dead weight ofthe handle flopping uncontrollably while the delivery system is graspedadjacent the distal end of sheath 14 to insert distal portion 24 intothe working lumen. Such a structure will have a wide variety ofapplications for guidewires and guidewire-like structures havingproximal handles for facilitating insertion of their distal ends intolumens of vascular access catheters, insertion sheaths, monorailcatheter lumens, and the like.

[0105] Referring now to FIG. 13, a variety of alternative deploymentmethods might be used to deploy the contraceptive system 10. Forexample, using a simple cervical catheter 102, deployment might bedirected sonographically, fluorscopically, under magnetic resonanceimaging, and possibly even solely from tactile information. In thealternative exemplary method illustrated in FIG. 13, a balloon 104 ofcervical catheter 102 is inflated via inflation port 106. This allowsthe uterus U to be distended by introduction of distention media througha uterine catheter 108 inserted through the working lumen of cervicalcatheter 102. Preferably, anatomy and target location identification,device positioning, deployment, detachment, and position confirmation(as outlined in method 2 with reference to FIG. 1A) is performed underthe guidance of ultrasound and/or fluoroscopic imaging. Relevant uterinecatheter manipulation structures and methods are described in U.S. Pat.Nos. 5,346,498; and 5,389,100, the full disclosure of which areincorporated herein by reference.

[0106] As described above, the delivery systems of the present inventionwill often hold the contraceptive device in a fixed position while thecontraceptive device is uncovered, expanded, and/or released. Whenmoving, for example, outer sheath 14 so as to expose the proximalportion of the contraceptive device, friction between the outer sheathand the surrounding hysteroscope (or other introducing structure,surrounding tissue, or the like) may cause inadvertent movement of thecontraceptive device. To avoid such inadvertent movement, an outersleeve may be slidably disposed around outer sheath 14. The sleeveprovides a sliding interface between the sheath and surroundingstructures. By axially coupling the sleeve and core shaft 18, frictionbetween the sleeve and surrounding structures may inhibit movement ofthe contraceptive device.

[0107] Referring now to FIGS. 14A and 14B, a sleeve 112 is slidablydisposed around at lease a proximal portion of sheath 14. Sleeve 112 isaxially restrained relative to core shaft 18 by axially connecting theproximal end of the sleeve to housing 110 of handle 30 c′, optionallyusing a rotatable connector 114 (to allow the sleeve to rotate relativeto the housing). Sleeve 112 will often have a distal end disposedproximally of contraceptive device 12.

[0108] As can be seen in FIG. 14B, sleeve 112 will often advance into asealing introducer structure such as a nipple value V of hysteroscope S.Sleeve 112 may also extend at least through the bend where a workinglumen WL of the hysteroscope joins the main shaft of the scope. Sleeve112 allows independent movement of sheath 14 despite frictionalengagement between the sleeve and nipple valve V, and between the sleeveand working lumen WL. Rotatable connector 114 allows free rotation ofhandle 30 c′ (and core shaft 18) during disengagement of the core shaftfrom the contraceptive device.

[0109] Referring now to FIGS. 15 and 16, an alternative contraceptivesystem 150 includes a contraceptive device 152 having many of thecomponents described above, but having an alternative wind-down outercoil connector 154 disposed at a proximal end of outer coil 56. Analternative release catheter 158 having a corresponding connector 160for engagement with connector 154 of contraceptive device 152 againallows a wind-down torque to be releasably maintained, as describedabove. In this embodiment, wind-down connector 160 of release catheter158 comprises an opening which receives a protrusion 162 extendingradially from a tubular band of connector 154. These alternativeconnectors, as well as further alternative threaded connectors 170, 172for releasable engagement between the primary coil and core wire, aremore fully described in an application entitled “Insertion/DeploymentCatheter System for Intrafallopian Contraception” (previouslyincorporated herein by reference), which is filed concurrently herewith.One or more of these connector structures will preferably provide a highcontrast image under at least one known medical imaging modality. Suchmarkers can help positioning of contraceptive device 150, and/orverification of disengagement between corresponding connectors(particularly when each of the engaging connectors in a connector pairprovides a high imaging contrast).

[0110] Referring now to FIGS. 17 and 18, positioning surface 57 mayoptionally be affixed to sheath 14 to help axially positioncontraceptive device 152 across intermural region INT, as describedabove. Engagement between radially protruding positioning surface 57 andthe uterine tissue surrounding ostium O facilitates initial axialpositioning by taking advantage of the axial coupling of sheath 14 tothe contraceptive device. However, sheath 14 will often be withdrawnproximally into scope S early-on during deployment, and it is oftendesirable to maintain the axial position of the contraceptive device atleast until proximal coil 56 begins to expand radially.

[0111] As schematically illustrated in FIG. 17, by affixing axialpositioning surface 57 (which may optionally comprise any of thealternative positioning surface configurations described hereinabove, orstill further alternative structures) at a distal end of a separatepositioning catheter 184 slidably disposed over sheath 14, the axialpositioning provided by the positioning surface may be maintained duringand/or after withdrawal of sheath 14.

[0112] Referring now to FIGS. 17 and 19, a proximal portion 186 ofpositioning catheter 184 may be axially coupled to a distal portion ofhandle 30. This arrangement is fairly easy to manufacture, andeffectively axially couples contraceptive device 152 to positioningsurface 57 via handle 30. Alternatively, positioning catheter 184 may beaxially coupled to the release catheter within sheath 14, or to any ofthe other axially elongate delivery system components extending distallyfrom the handle.

[0113] Note that if positioning surface 57 extends distally of theproximal end of outer coil 56, it is possible that the proximal portionof the outer coil will expand partially in the positioning catheter,particularly where the positioning catheter is affixed axially to handle30 and handle 30 is affixed axially to the core wire. Axial coupling ofthe positioning catheter to the release catheter (rather than the corewire) may allow at least partial withdrawal of the positioning catheterprior to expansion of the outer coil. In some embodiments, a distalportion of positioning catheter 184, positioning surface 57, and/or aproximal portion of outer coil 56 may be adapted so as to facilitateproximal withdrawal of the positioning catheter after the outer coil hasexpanded, such as by limiting a diameter of a proximal portion of theouter coil, providing a low friction surface along an inner lumen of therelease catheter and/or along the outer surface of the proximal portionof the outer coil, or the like. Fortunately, the relatively highfriction outer surface of the distal portion of outer coil 56 within theostium of the fallopian tube will help inhibit axial movement of thecontraceptive device after sheath 14 is withdrawn proximally.

[0114] Referring now to FIG. 20, an alternative outer sheath 214 may beused in place of outer sheath 14 in the system of FIG. 1B. Sheath 214has a proximal portion 216 with a relatively stiff, thicker-walledtubular structure, such as a PeBax® polymer tube having an outerdiameter of about 0.062″, and an inner diameter of about 0.042″. Adistal portion of sheath 14 includes an inner tube 218 of a low frictionpolymer and an outer tube 220 of a polymer, (such as carbothane™ 73A)with at least one ribbon coil 222 therebetween. Inner tube 218 maycomprise a PTFE (such as a Teflon® material) with an inner diameter ofabout 0.034″ and a wall thickness of about 0.001″ with the outerdiameter etched, and a length of about 5.0 cm, while there arepreferably two counterwound ribbon coils 222 of a superelastic or shapememory alloy, such as nickel titanium (optionally with chromium) ofabout 0.007″ by about 0.010″ with a pitch of about 0.015″ and a lengthof about 4.0 cm. Inner tube 218 might alternatively comprise ETFE, gammastable PTFE, FEP, or the like, while ribbon coils 222 may comprise astainless steel or other medical grade materials. An inner diameter ofthe distal portion may be about 0.034″, with the distal outer diameterof sheath 214 being about 0.041″. An intermediate outer tube 224 maycomprise a polyurethane having a durometer of about 55. A length ofouter tube 220 may be about 1.0 cm, a length of intermediate tube 224may be about 5 mm, and a length of proximal portion 216 may be about 40cm.

[0115] Referring now to FIG. 21, a still further alternative proximalhandle 230 includes many of the axial movement components of handle 30c, as described above. Rather than providing a rotatable knob 41,detachment of the contraceptive device from the core wire 18 of thedelivery system may be effected by rotation of handle 230 about the axisof the corewire. Still further options are possible, including thedetachment of a distal portion of the corewire from the proximalportion, so that the distal portion remains within the contraceptivedevice after deployment.

[0116] While the exemplary embodiment of the present invention has beendescribed in some detail, for clarity of understanding and by way ofexample, a variety of adaptations, changes, and modifications will beobvious to those who are skilled in the art. Hence, the scope of thepresent invention is limited solely by the independent claims.

What is claimed is:
 1. A contraceptive delivery system comprising: acontraceptive device configured to be insertable into an ostium of afallopian tube; a sheath having a proximal end, a distal end and a lumentherethrough, the lumen forming a receptacle at the distal end, thereceptacle configured to releasably receive the contraceptive device; apositioning catheter having a proximal end, a distal end and a lumentherethrough, wherein the sheath is slidably disposed within the lumenof the positioning catheter; at least one mechanism, wherein actuationof the at least one mechanism moves the proximal end of the sheathproximally within the positioning catheter exposing the contraceptivedevice so as to release the contraceptive device within the fallopiantube while the positioning catheter does not move axially relative tothe ostium.
 2. The system of claim 1, wherein the contraceptive deviceis reducible in size so that the contraceptive device fits within thereceptacle in a compressed state.
 3. The system of claim 1, wherein thecontraceptive device comprises a plug.
 4. The system of claim 1, furthercomprising a first elongate body having a proximal end and a distal endreleasably contactable with the contraceptive device, the distal enddisposed within the lumen of the sheath and adjacent to the receptacle.5. The system of claim 4, wherein the first elongate body maintains thecontraceptive device in position within the fallopian tube while thesheath is pulled proximally.
 6. A system of claim 5, wherein firstelongate body extends through at least a portion of the sheath to thereceptacle.
 7. The system of claim 1, wherein the mechanism is manuallyactuatable.
 8. The system of claim 7, wherein the mechanism isactuatable from outside of a body having the ostium of the fallopiantube.
 9. The system of claim 1, wherein the at least one mechanism iscapable of moving the proximal end of the sheath relative to thepositioning catheter.
 10. The system of claim 1, wherein exposure of thecontraceptive device releases the contraceptive device within theostium.
 11. A contraceptive method comprising: providing a sheath havinga proximal end, a distal end and a lumen therethrough, the lumen forminga receptacle at the distal end, and a contraceptive device disposedwithin the receptacle; inserting the sheath into an ostium of afallopian tube; and moving the sheath proximally relative to the ostiumso that such movement of the sheath exposes the contraceptive device andallows release of the contraceptive device into the fallopian tube. 12.The method of claim 11, wherein inserting the sheath includespositioning the sheath so that the contraceptive device is in a desiredlocation within the fallopian tube and moving the sheath includes movingthe sheath relative to the ostium so that the contraceptive deviceremains in the desired location.
 13. The method of claim 12, whereinproviding includes providing a first elongate body having a proximal endand a distal end releasably contactable with the contraceptive deviceand wherein at least the distal end is disposed within the lumen of thesheath adjacent to the receptacle, and further comprising maintainingcontact between the first elongate body and the contraceptive deviceduring proximal movement of the sheath.
 14. The method of claim 13,wherein moving the sheath includes actuating a mechanism which moves thesheath.
 15. The method of claim 14, wherein actuating the mechanismincludes manually actuating the mechanism.
 16. The method of claim 15,wherein manually actuating the mechanism is achievable outside of a bodyhaving the ovarian pathway of the fallopian tube.
 17. The method ofclaim 11, wherein providing includes providing a positioning catheterhaving a proximal end, a distal end and a lumen therethrough, wherein atleast a portion of the sheath is disposed within the lumen of thepositioning catheter.
 18. The method of claim 17, wherein moving thesheath includes moving the proximal end of the sheath relative to thepositioning catheter.
 19. The method of claim 18, wherein at least aportion of the positioning catheter is configured to maintain positionrelative to the ostium while the sheath moves.